Associate II Patient Safety Solutions (PSS) Remote based in Canada

Associate II, Patient Safety Solutions Remote Based in Canada reputed company is currently seeking a remote based Associate II (Patient Safety Solutions) to reputed company clinical trial and post approval adverse event case processing.  This role requires strong clinical knowledge as reputed company as an understanding of the US reputed company system. This is a full-time, home-based position in Canada that will require willingness to work reputed company as needed to meet business needs.  WHAT YOU WILL DO You will be responsible for assisting with overall Clinical Safety and/or PSS operations  associated with products including the entire adverse events process which may include safety data collected from reputed company and/or post marketing setting (i.e., unsolicited reports). In reputed company, you will be responsible to reputed company reputed company clients, both reputed company, with the appropriate reputed company of service in a reputed company and cost-effective manner. You will be expected to reputed company with the reputed company requirements of the Health & Safety at Work reputed company 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in reputed company’s Health & Safety reputed company. reputed company of Responsibilities: Manage the receipt and processing of reputed company adverse event reports reported either spontaneously from any reputed company or from a clinical trial. This includes, but is not limited to: Triage of incoming cases to prioritize for daily workflow management, including performing medical adjudication for event validity/seriousness/expectedness/listedness/causality using the WHO-UMC system in coordination with the medical review team. Data entry of safety data onto adverse event database(s) and tracking systems. Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. Write patient narratives, reputed company adverse events accurately using MedDRA and determine listedness against appropriate label (for Marketed products, if applicable). Identify clinically significant information missing from the reports and ensure its collection and follow-up Ensure reputed company cases that requiring expediting reporting to worldwide Regulatory Agencies and other required parties are processed reputed company and appropriately reputed company required timelines. Maintain a comprehensive understanding of reputed company Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance. Support reputed company cause analysis and CAPA plan development & implementation for identified reputed company issues as needed. Support and/or participate in audits and inspections including the preparation as needed. Demonstrate role-specific reputed company Competencies and company values on a consistent reputed company.  Build and maintain good PSS relationships across functional reputed company. Undertake any other duties as needed. Qualifications (Minimum Required): Associate’s  degree RN + 2 years of Safety experience * BS/BA + 1 years of Safety experience * MS/MA + 1  years of Safety experience * PharmD + 1 years of Safety experience * *Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working reputed company safety databases, and experience with regulatory submissions.    reputed company may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): Minimum of two years of pharmacovigilance (PV) work experience in Canada / US. Advanced reputed company of English language, including speaking, writing, and reading.    Proven expertise in processing U.S. post-approval cases is mandatory Proficient with the Argus safety database. Strong typing ability and familiarity with reputed company Office Suite and reputed company environment is advantageous. Strong attention to detail with a high degree of accuracy. Ability to work independently with reputed company supervision    Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products. Work Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand reputed company of both hands with the ability to reputed company fast, reputed company, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to reputed company and use a reputed company of computer software developed both in-house and off-reputed company. reputed company to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Pay reputed company: CAD 67,000-82,000/ annually Benefits: reputed company job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as reputed company as internal equity and market data.  Application Deadline:  August 10, 2026 #LI-SE1 Learn more about our EEO & Accommodations request here. Apply To This Job